NCT02255916

Brief Summary

The purpose of this study is to determine the effects of live sound-bed music on physiological and psychological parameters in staff of a hospital oncology ward.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

September 9, 2014

Last Update Submit

January 12, 2015

Conditions

Healthy Adults (Hospital Oncology Ward)Physiological Phenomena (e.g.HRV Parameters)Morphology

Keywords

oncologypsychologycancermusicsound-bed

Outcome Measures

Primary Outcomes (1)

  • Basler Mood Questionnaire (BBS)

    filled in by the participants four times (before and after the music intervention respectively no intervention)

    30 minutes

Secondary Outcomes (16)

  • additional questions addressing body warmth, subjective painlessness and general mental state

    30 minutes

  • heart rate variability -Parameter (HRV)

    Physiological parameters are measured twice over a period of 2 hours.

  • HRV-Parameter

    Physiological parameters are measured twice over a period of 2 hours.

  • HRV-Parameter

    Physiological parameters are measured twice over a period of 2 hours.

  • HRV-Parameter

    Physiological parameters are measured twice over a period of 2 hours.

  • +11 more secondary outcomes

Study Arms (2)

Controll

NO INTERVENTION

No sound-bed intervention

Music

EXPERIMENTAL

live sound-bed music intervention

Other: Music

Interventions

MusicOTHER

live sound-bed music intervention

Music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent of the participant
  • affiliation to the staff of the hospital oncology ward

You may not qualify if:

  • insufficient knowledge of the German language
  • alcohol, caffeine or nicotine less than 3 hours before the beginning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan Vagedes, Dr.

    ARCIM-Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

October 3, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations

DE(1)